The challenges of making informed decisions about treatment and trial participation following a cancer diagnosis: a qualitative study involving adolescents and young adults with cancer and their caregivers
Research Article
Ruth I. Hart, David A. Cameron, Fiona J. Cowie, Jeni Harden, Nicholas B. Heaney, David Rankin, Angela B. Jesudason, Julia Lawton
BMC Health Services Research, 8 January 2020; 20(25)
Open Access
Abstract
Background
Limited attention has been paid to adolescents and young adults’ (AYA’s) experiences in the aftermath of a cancer diagnosis, despite this being a time when potentially life-changing decisions are made. We explored AYA’s and caregivers’ experiences of, and views about, making treatment and trial participation decisions following a cancer diagnosis, in order to understand, and help facilitate, informed treatment decision-making in this age group.
Methods
Interviews were undertaken with 18 AYA diagnosed, or re-diagnosed, with cancer when aged 16–24 years, and 15 parents/caregivers. Analysis focused on the identification and description of explanatory themes.
Results
Most AYA described being extremely unwell by the time of diagnosis and, consequently, experiencing difficulties processing the news. Distress and acceleration in clinical activity following diagnosis could further impede the absorption of treatment-relevant information. After referral to a specialist cancer unit, many AYA described quickly transitioning to a calm and pragmatic mind-set, and wanting to commence treatment at the earliest opportunity. Most reported seeing information about short-term side-effects of treatment as having limited relevance to their recovery-focused outlook at that time. AYA seldom indicated wanting to make choices about front-line treatment, with most preferring to defer decisions to health professionals. Even when charged with decisions about trial participation, AYA reported welcoming a strong health professional steer. Parents/caregivers attempted to compensate for AYA’s limited engagement with treatment-relevant information. However, in seeking to ensure AYA received the best treatment, these individuals had conflicting priorities and information needs.
Conclusion
Our study highlights the challenging context in which AYA are confronted with decisions about front-line treatment, and reveals how their responses make it hard to ensure their decisions are fully informed. It raises questions about the direct value, to AYA, of approaches that aim to promote decision-making by improving understanding and recall of information, though such approaches may be of value to caregivers. In seeking to improve information-giving and involvement in treatment-related decision-making at diagnosis, care should be taken not to delegitimize the preference of many AYA for a directive approach from trusted clinicians.

Adolescent Consent to Vaccination in the Age of Vaccine-Hesitant Parents
Viewpoint
Tony Yang, Robert S. Olick, Jana Shaw
JAMA Pediatrics, 7 October 2019;173(12) pp 1123-112
Excerpt
As children of vaccine-hesitant parents become adolescents, they develop their individual perspectives on vaccination. One of these adolescents, Ethan Lindenberger, researched vaccines, discussed them with trusted adults, and ultimately got vaccinated.1 His testimony to the Senate Committee on Health, Education, Labor and Pensions made national headlines.1 Many other adolescents are similarly seeking advice on how to get vaccinated. While vaccination against measles and other conditions occurs in early childhood, vaccine-hesitant parents have also refused human papillomavirus vaccination, routinely provided for adolescents beginning at age 11 or 12 years. And they have refused to let their children catch up on any missed early childhood vaccinations. Prior research has shown that adolescents feel generally marginalized in the decision-making process, yet they desire to participate in decisions.2 Their main obstacle to vaccination is that most states require an individual to be 18 years or older to consent to medical procedures.3 We argue for expansion of the rights of adolescents to make their own decisions to be vaccinated against serious and potentially life-threatening diseases without requiring parental consent and involvement…

Consent in children’s intensive care: the voices of the parents of critically ill children and those caring for them
Original research
Phoebe Aubugeau-Williams, Joe Brierley
Journal of Medical Ethics, 27 November 2019
Abstract
Despite its invasive nature, specific consent for general anaesthesia is rarely sought—rather consent processes for associated procedures include explanation of risk/benefits. In adult intensive care, because no one can consent to treatments provided to incapacitated adults, standardised consent processes have not developed. In paediatric intensive care, despite the ready availability of those who can provide consent, no tradition of seeking it exists, arguably due to the specialty’s evolution from anaesthesia and adult intensive care. With the current Montgomery-related focus on consent, this seems untenable. We undertook a qualitative study in a specialist children’s hospital colocated paediatric/neonatal intensive care (same medical team) in which parental acceptance of admission and entailed procedures is considered implied by virtue of that admission. Semistructured interviews were carried out with both staff and parents to investigate their views about consent, the current system and a proposed blanket consent system, in which parents actively consent at admission to routine procedures. Divergent views emerged: staff were worried that requiring consent at admission might prove a further emotional burden, whereas parents found providing consent a way of coping, feeling empowered and maintaining control. Inconsistencies were found in the way consent is obtained for your routine procedures. Practice does seem inconsistent with contemporary consent standards for medical intervention. Our findings support the introduction of a blanket consent system at admission together with ongoing bedside dialogue to ensure continuing consent. Both parents and staff expressed concern about avoiding possible harmful delays to children due to parental emotional overload and language difficulties.

Informed consent as a situated research process in an ethnography of incarcerated youth in Denmark [BOOK CHAPTER]
Tea Terbenfeldt Bengtsson
Complexities of Researching with Young People, December 2019; chapter 10
Excerpt
In this chapter I reflect on the complexities of obtaining informed consent when doing ethnography with incarcerated youth. Through concrete examples, it is demonstrated that it is often impossible to obtaining informed consent through standardized research practice. Thus, informed consent cannot be standardized if we are to conduct ethically grounded ethnographies with vulnerable youth but must be developed as a situated research practice throughout the research process…

Informed Consent From Children
Tim Moore
SAGE Research Methods Foundations, 9 September 2019
Abstract
Children’s informed consent in participatory research is an essential component to ethical research practice. Although there has been significant attention from researchers about the importance of seeking children’s informed consent prior to their participation in data collection, some commentators see consent as an ongoing process rather than a hurdle to be overcome prior to data collection. After discussing the participation of children in research, this entry presents five steps that may help researchers consider how to embed informed consent in research activities as well as examples to show how researchers can assist children to understand, indicate, utilize, and reflect on their consent.

Variability in Informed Consent Practices for Non-Emergent Procedures in Pediatric Emergency Departments
Research Article
Lorrie Edwards, Heidi Werner, Yorghos Tripodis, David Dorfman, Tehnaz Boyle, Megan Bair-Merritt, Arvin Garg
Clinical Pediatrics, 26 September 2019 
Abstract
Although informed consent is a cornerstone of medical ethics, it is unclear if the practice for obtaining informed consent is consistent among pediatric emergency departments. This study’s goal is to describe the current practice for written informed consent in academic pediatric emergency departments for non-emergent procedures. A questionnaire distributed to pediatric emergency medicine fellowship directors queried whether written informed consent was standard of care for 15 procedures and assessed departmental consent policies and use of “blanket” consent-to-treat forms. Response rate was 80% (n = 64). Institutions obtained written consent for a mean of 4.4 procedures. Written informed consent was most commonly obtained for procedural sedation (82.5%), blood transfusion (72.9%), and lumbar puncture (66.5%). Twenty-one institutions (32.8%) had policies specifying procedures requiring written consent. Thirty-five institutions (54.7%) used “blanket” consent-to-treat forms. Our results suggest that there is variability in the use of written informed consent for non-emergent procedures among academic pediatric emergency departments.

Optimising informed consent in school-based adolescent vaccination programmes in England: A multiple methods analysis
Tracey Chantler, Louise Letley, Pauline Paterson, Joanne Yarwood, Vanessa Saliba, Sandra Mounier-Jack
Vaccine, 24 July 2019
Open Access
Abstract
The process of obtaining informed consent for school-based adolescent immunisation provides an opportunity to engage families. However, the fact that parental consent needs to be obtained remotely adds complexity to the process and can have a detrimental effect on vaccine uptake. We conducted a multiple methods analysis to examine the practice of obtaining informed consent in adolescent immunisation programmes. This involved a thematic analysis of consent related data from 39 interviews with immunisation managers and providers collected as part of a 2017 service evaluation of the English adolescent girls’ HPV vaccine programme and a descriptive statistical analysis of data from questions related to consent included in a 2017 survey of parents’ and adolescents’ attitudes to adolescent vaccination. The findings indicated that the non-return of consent forms was a significant logistical challenge for immunisation teams, and some were piloting opt-out consent mechanisms, increasing the proportion of adolescents consenting for their own immunisations, and introducing electronic consent. Communicating vaccine related information to parents and schools and managing uncertainties about obtaining adolescent self-consent for vaccination were the main practical challenges encountered. Survey data showed that parents and adolescents generally agreed on vaccine decisions although only 32% of parents discussed vaccination with their teenager. Parental awareness about the option for adolescents to self-consent for vaccination was limited and adolescents favoured leaving the decision-making to parents. From the interviews and variability of consent forms it was evident that health professionals were not always clear about the best way to manage the consent process. Some were also unfamiliar with self-consent processes and lacked confidence in assessing for ‘Gillick competency’. Developing pathways and related interventions to improve the logistics and practice of consent in school-based adolescent immunisation programmes could help improve uptake.

Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?
Perspective
Ross D. Silverman, Douglas J. Opel, Saad B. Omer
New England Journal of Medicine, 11 July 2019; 381(2)
Excerpt
…Such cases raise the question of whether adolescent minors should be able to consent to vaccinations without parental permission. For minors to be able to choose to be vaccinated over parental objections, most states would need to make substantive changes to laws governing medical consent. Since children are generally considered nonautonomous under U.S. law, treatment of a child in a medical setting requires parental permission, typically until a child reaches 18 years of age. Parents are generally given broad discretion in making decisions on behalf of their children, in part because they know their child best, are positioned to weigh competing family interests, and are permitted to raise their child as they choose. Such discretion doesn’t mean that adolescents have no role in decisions that affect them, however. Out of respect for adolescents’ developing autonomy, clinicians routinely explore their understanding of health-related issues, solicit their agreement on care plans, navigate discordance between parental and adolescent preferences, and protect adolescents’ confidentiality interests.

Both ethical principles and state laws also support independent decision making by adolescents in cases in which failing to grant adolescents autonomy could foreseeably result in substantial risk to the minor or to public health. For instance, all states have laws permitting minors to make independent, confidential clinical decisions regarding certain sensitive or stigmatized health care services, such as those related to sexual health, reproduction, mental health, and substance use disorders. Roughly 20% of jurisdictions require adolescents to be at least 12 or 14 years of age to make such decisions; others don’t designate a minimum age of consent.3 A court may also grant an older adolescent (typically 16 years or older) legal emancipation or deem the adolescent to be a “mature minor” who is able to make certain decisions independently.

Most states, however, don’t authorize adolescents to independently consent to vaccination…

Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials
Susan M. Abdel-Rahman
Pediatric Drugs, 17 July 2019; pp 1-10
Abstract
Individuals approached to participate in human subjects research, irrespective of age, must be completely apprised of the study, and researchers must ensure that the information is understood to the fullest extent possible, prior to decision making. However, evolving regulatory and institutional requirements have led to permission/assent/consent (PAC) forms that are unnecessarily complex, serving only to exacerbate the challenges associated with communicating this important information to prospective participants. At greatest risk are children and other individuals with low literacy, limited English proficiency, and diminished mental capacity, populations all too often neglected in clinical research. This paper examines various strategies that have been evaluated to facilitate informed PAC, drawing on experiences across a broad array of populations whose needs overlap with those of children. These strategies range from simplifying PAC forms for readability and creating multimedia PAC delivery tools to actively engaging participants on their understanding of PAC elements by leveraging testing, rewards, and third-party communications. Notably, the findings from strategies that have been explored in more than one setting are uniformly mixed with respect to their ability to improve comprehension, underscoring the challenges that persist in designing, implementing, and objectively examining strategies intended to facilitate informed PAC. However, these studies do serve to highlight efforts that may reduce anxiety around, and increase the satisfaction of participants with, the PAC process. Ultimately, accommodating a diverse participant pool will require the consideration, and continual refinement, of various PAC strategies along with the engagement of team members who are intimately familiar with these populations.